Camu Camu effects on microbial translocation and systemic immune activation in ART-treated people living with HIV: protocol of the single-arm non-randomised Camu Camu prebiotic pilot study (CIHR/CTN PT032). Issue 1 (17th January 2022)

• Record Type: Journal Article
• Authors: Isnard, Stéphane; Fombuena, Brandon; Ouyang, Jing; Royston, Léna; Lin, John; Bu, Simeng; Sheehan, Nancy; Lakatos, Peter L; Bessissow, Talat; Chomont, Nicolas; Klein, Marina; Lebouché, Bertrand; Costiniuk, Cecilia T; Routy, Bertrand; Marette, André; Routy, Jean-Pierre
• Is Part Of: BMJ open. Volume 12:Issue 1(2022)
• Publication Date: 2022-01-17
• Subjects: HIV & AIDS -- inflammatory bowel disease -- nutritional support -- immunology; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2021-053081
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: Despite the success of antiretroviral therapy (ART) in transforming HIV disease into a chronic infection, people living with HIV (PLWH) remain at risk for various non-AIDS inflammatory comorbidities. Risk of non-AIDS comorbidities is associated with gut dysbiosis, epithelial gut damage and subsequent microbial translocation, and increased activation of both circulating CD4+ and CD8+ T-cells. Therefore, in addition to ART, novel gut microbiota-modulating therapies could aid in reducing inflammation and immune activation, gut damage, and microbial translocation. Among various gut-modulation strategies under investigation, the Amazonian fruit Camu Camu (CC) presents itself as a prebiotic candidate based on its anti-inflammatory and antioxidant properties in animal models and tobacco smokers. Method and analysis: A total of 22 PLWH on ART for more than 2 years, with a viral load <50 copies/mL, a CD4 +count >200 and a CD4+/CD8 +ratio <1 (suggesting increased inflammation and risk for non-AIDS comorbidities), will be recruited in a single arm, non-randomised, interventional pilot trial. We will assess tolerance and effect of supplementation with CC in ART-treated PLWH on reducing gut damage, microbial translocation, inflammation and HIV latent reservoir by various assays. Ethics and dissemination: The Canadian Institutes of Health Research (CIHR)/Canadian HIV Trials Network (CTN) pilot trial protocol CTNPT032 was approved by the Natural and Non-prescription Health Products Directorate of Health Canada and the research ethics board of the McGill university Health Centre committee (number 2020-5903). Results will be made available as free access through publications in peer-reviewed journals and through the CIHR/CTN website. Trial registration number: NCT04058392 .